(a) Treatment of product water.

1. (1) All treatment of product water by distillation, ion-exchanging, filtration, ultraviolet treatment, reverse osmosis, carbonation, mineral addition, or any other process shall be done in a manner so as to be effective in accomplishing its intended purpose.

2. (2) All such processes shall be:

   1. (A) Performed in and by equipment; and
   2. (B) With substances which will not adulterate the bottled product.
3. (3) A record of the type and date of physical inspections of such equipment, conditions found, and the performance and effectiveness of such equipment shall be maintained by the plant.
4. (4) Product water samples shall be taken after processing and prior to bottling by the plant and analyzed as often as is necessary to ensure uniformity and effectiveness of the processes performed by the plant.
5. (5) The methods of analysis shall be those approved by the Department of Health.
6. (6) All water treatment devices and chemicals shall be certified as meeting ANSI/NSF Standards 60 and 61, as appropriate, in accordance with the Rules Pertaining to Public Water Systems, 20 CAR pt. 140.

(b) Containers.

1. (1)

   1. (A) Multiservice primary containers shall be adequately cleaned, sanitized, and inspected just prior to being filled, capped, and sealed.
   2. (B) Containers found to be unsanitary or defective by the inspection shall be reprocessed or discarded.
   3. (C) All multiservice primary containers shall be washed, rinsed, and sanitized by mechanical washers or by any other method giving adequate sanitary results.

2. (2)

   1. (A) Mechanical washers shall be inspected as often as is necessary to ensure adequate performance.
   2. (B) Records of physical maintenance, inspections and conditions found, and performance of the mechanical washer shall be maintained by the bottled water plant.

3. (3)

   1. (A) Multiservice shipping cases shall be maintained in such condition as to ensure they will not contaminate the primary container or the product water.
   2. (B) Adequate dry or wet cleaning procedures shall be performed as often as necessary to maintain the cases in satisfactory condition.

(c) Cleaning and sanitizing solutions.

1. (1) Cleaning and sanitizing solutions utilized by the plant shall be sampled and tested by the plant as often as is necessary to ensure adequate performance in the cleaning and sanitizing operations.
2. (2) Records of these tests shall be maintained by the plant.

(d) Sanitizing operations.

1. (1) Sanitizing operations, including those performed by chemical means or by any other means such as circulation of live steam or hot water, shall be adequate to effect sanitization of the intended product water-contact surfaces and any other critical area.
2. (2) The plant should maintain a record of the intensity of the sanitizing agent and the time duration that the agent was in contact with the surface being sanitized.

3. (3) The following times and intensities shall be considered a minimum:

   1. (A) Steam in enclosed system. At least one hundred seventy degrees Fahrenheit (170˚ F) for at least fifteen (15) minutes or at least two hundred degrees Fahrenheit (200˚ F) for at least five (5) minutes;
   2. (B) Hot water in enclosed system. At least one hundred seventy degrees Fahrenheit (170˚ F) for at least fifteen (15) minutes or at least two hundred degrees Fahrenheit (200˚ F) for at least five (5) minutes; and
   3. (C)

(i) Chemical sanitizers shall be equivalent in bactericidal action to a two-minute exposure of fifty parts per million (50 ppm) of available chlorine at fifty-seven degrees Fahrenheit (57˚ F) when used as an immersion or circulating solution.

1. (ii) Chemical sanitizers applied as a spray or fog shall have as a minimum one hundred parts per million (100 ppm) of available chlorine at fifty-seven degrees Fahrenheit (57˚ F) or its equivalent in bactericidal action.

   1. (iii) One-tenth part per million (0.1 ppm) ozone water solution in an enclosed system for at least five (5) minutes.

      1. (iv) Sanitizers shall be removed from the surface of the container by a rinsing procedure.
      2. (v) The final rinse, prior to filling the container with product water, shall be performed with a disinfected water rinse free of pathogenic bacteria or by an additional sanitizing procedure equivalent in bactericidal action to that required in paragraph (d)(3) of this section.

(e) Unit package production code.

1. (1) Each unit package from a batch or segment of a continuous production run of bottled drinking water shall be identified by a production code.
2. (2) The production code shall identify a particular batch or segment of a continuous production run and the day produced.
3. (3) The plant shall record and maintain information as to the kind of product, volume produced, date produced, lot code used, and the distribution of the finished product to wholesale and retail outlets.

(f) Filling, capping, or sealing.

1. (1)

   1. (A) During the process of filling, capping, or sealing either single-service or multiservice containers, the performance of the filler, capper, or sealer shall be monitored and the filled containers visually or electronically inspected to ensure they are:

      1. (i) Sound;
      2. (ii) Properly capped or sealed; and
      3. (iii) Coded and labeled.
   2. (B) Containers which are not satisfactory shall be reprocessed or rejected.
   3. (C) Only nontoxic containers and closures shall be used.

2. (2) Sampling.

   1. (A) All containers and closures shall be sampled and inspected to ascertain that they are free from contamination.
   2. (B) At least once each three (3) months, a bacteriological swab or rinse count or both should be made from at least four (4) containers and closures selected just prior to filling and sealing.

   3. (C) No more than one (1) of the four (4) samples may exceed more than one (1):

      1. (i) Bacteria per milliliter of capacity; or
      2. (ii) Colony per square centimeter of surface area.
   4. (D) All samples shall be free of coliform organisms.
   5. (E) The procedure and apparatus for these bacteriological tests shall be in conformance with those recognized by the department.
   6. (F) Tests shall be performed either by qualified plant personnel or a competent commercial laboratory.

(g) Compliance procedures. To ensure that the plant's production of bottled drinking water complies with the applicable standards, laws, and rules of the department, the plant will analyze product samples as follows:

1. (1)

   1. (A) For bacteriological purposes, take and analyze at least once a week a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production.
   2. (B) The representative sample shall consist of primary containers of product or unit packages of product; and

2. (2)

   1. (A) Analyze such samples by methods approved by the department.
   2. (B) The plant shall maintain records of date of sampling, type of product sampled, production code, and results of the analysis.

(h) Record retention.

1. (1) All records required shall be maintained at the plant for not less than two (2) years.
2. (2) Plants shall also retain on file at the plant current certificates or notifications of approval issued by the department approving the plant's source and supply of product water and operations water.
3. (3) All required documents shall be available for official review at reasonable times.

4. (4) All records relating to water quality shall be retained in accordance with the requirements of the National Primary Drinking Water Regulations, 40 C.F.R. pt. 141.

   1. (i) Recall procedure.

5. (1) Each bottled water plant operator shall:

   1. (A) Develop and maintain procedures for the notification of the department, consumer notification, and product recall; and
   2. (B) Implement any said procedure as necessary with respect to any product for which the operator or department knows or has reason to believe circumstances exist that may adversely affect its safety for the consumer.

6. (2) In order to facilitate product identification or recall, each bottled water product shall contain a code that:

   1. (A) Is designed to remain affixed to the container during use; and
   2. (B) Contains the date of manufacture and the batch or segment number.